Medical Device Supplier Management: Definition, Requirements, and Process

Medical device supplier management is a structured process for selecting, qualifying, controlling, and monitoring external suppliers and subcontractors whose products or services directly impact device quality, safety, and regulatory conformity.

Manufacturers must implement supplier controls in accordance with ISO 13485:2016 Clause 7.4, FDA 21 CFR Part 820.50, EU MDR, and EU IVDR. These include documented supplier qualification procedures, risk-based monitoring and re-evaluation, traceable purchasing records, and oversight of outsourced processes to ensure regulatory compliance and product conformity. For drug-device combination products, additional requirements for the pharmaceutical part under Good Manufacturing Practice (GMP) may also apply.

The supplier management process follows a lifecycle approach. The lifecycle approach involves supplier identification, supplier’s risk classification, supplier qualification based on predefined criteria, onboarding, and inclusion in the Approved Supplier list (ASL). After supplier inclusion, ongoing supplier management activities include performance monitoring using defined Key Performance Indicators (KPIs), management of supplier-related nonconformities and Corrective and Preventive Actions (CAPAs), change control, and requalification. These supplier management activities ensure supplier oversight and continuous compliance with regulatory requirements.

Validated QMS software supports supplier lifecycle management by automating qualification workflows, managing supplier documentation, and linking supplier records, including audit reports, CAPAs, Supplier Corrective Action Request (SCARs), and change controls to relevant QMS processes. QMS software supports traceability, maintains audit readiness, and ensures alignment with ISO 13485, 21 CFR Part 820, MDR, IVDR, and 21 CFR Part 11 data integrity requirements.

SimplerQMS provides a fully validated medical device QMS software with a supplier management functionality designed for life science companies.

What Is Medical Device Supplier Management?

Medical device supplier management is the systematic, risk-based oversight of external parties that provide materials, components, services, or processes impacting product quality, safety, or regulatory compliance. Supplier management ensures suppliers consistently meet defined quality and regulatory requirements throughout the product lifecycle.

Suppliers in the medical device sector may include raw material providers, Original Equipment Manufacturers (OEMs), sterilization vendors, contract manufacturers, software developers, calibration and testing services, and logistics partners. Suppliers have varying levels of risk and oversight associated with them, based on the nature and impact of their deliverables on product conformity.

The primary objective of medical device supplier management is to establish and maintain supplier conformity to purchasing controls under ISO 13485:2016 Clause 7.4 and 21 CFR 820.50, supporting device performance, patient safety, and audit readiness. Supplier management is a regulatory requirement and a critical quality system element audited by Notified Bodies and regulatory authorities.

Core elements of supplier management include supplier qualification, risk classification, quality agreements, performance monitoring, audit scheduling, nonconformance handling, and supplier re-evaluation. Supplier records must demonstrate traceability from supplier selection to CAPA or requalification decisions.

What Are Medical Device Supplier Management Requirements?

Listed below are the medical device supplier management requirements as defined by global standards and regulations.

• ISO 13485 Supplier Management Requirements: ISO 13485 requires documented procedures for evaluation, selection, performance monitoring, and re-evaluation of suppliers, with controls proportional to the risk and regulatory impact of supplied products or services (Clause 7.4.1).
• FDA 21 CFR Part 820 Supplier Management Requirements: 21 CFR Part 820 requires qualification and control of suppliers through documented criteria, quality agreements, and verification activities to ensure purchased products meet specified requirements and do not compromise finished device quality (21 CFR 820.50).
• Regulation (EU) 2017/745 on Medical Devices (MDR) Supplier Management Requirements: MDR Article 10 and Annex IX, Chapter I requires documented supplier controls for critical outsourced processes (such as sterilization or final release). Annex IX, Section 2.3, also requires notified bodies to audit suppliers and/or subcontractors to assess manufacturing and other relevant processes.
•  Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) Supplier Management Requirements: IVDR requires oversight of critical suppliers involved in design, manufacturing, and performance evaluation. Manufacturers must maintain technical documentation showing supplier conformity and implement supplier controls consistent with Article 10 of the IVDR. Annex IX requires notified bodies to audit suppliers and/or subcontractors to assess manufacturing and other relevant processes.
• Good Manufacturing Practice (GMP) Supplier Management Requirements for drug-device combination products: For drug-device combination products or components subject to drug GMPs, supplier qualification must comply with EU GMP, specifically, Chapter 5 (Production) and Chapter 7 (Outsourced Activities). These chapters require documented procedures for supplier selection, GMP-based qualification, and oversight of outsourced activities. Where the combination product is marketed in the U.S., applicable requirements for the pharmaceutical part under U.S. GMP (21 CFR Parts 210/211) must also be addressed.  
• Medical Device Single Audit Program (MDSAP) Supplier Management Requirements: MDSAP Chapter 7 requires documented procedures for supplier evaluation, purchasing controls, control of outsourced processes, and ongoing performance monitoring. Requirements are harmonized across participating regulatory authorities, the U.S. FDA, Health Canada, ANVISA (Brazil), TGA (Australia), and MHLW/PMDA (Japan).

ISO 13485 Supplier Management Requirements

ISO 13485:2016 is an international standard that specifies requirements for a Quality Management System (QMS) for organizations involved in all stages of the medical device lifecycle. It ensures that organizations consistently meet customer and applicable regulatory requirements through robust QMS processes.

Supplier management requirements under ISO 13485 are primarily defined in Clause 7.4, Purchasing, Clause 4.1.5, Control of outsourced processes, and supporting clauses such as 4.2.4, Control of documents, 4.2.5, Control of records, and 7.5.9.2, Traceability. These clauses establish how manufacturers must evaluate, select, control, and monitor suppliers of products and services that impact product conformity and regulatory compliance.

The primary supplier management requirements under ISO 13485:2016 are listed below.

• Supplier Evaluation and Selection: As per Clause 7.4.1, manufacturers must establish and document criteria for evaluating and selecting suppliers based on their ability to meet specified requirements and the associated risk. Organizations must maintain objective evidence of supplier capability, such as supplier qualification records.
• Supplier Monitoring and Re-evaluation: As per Clause 7.4.1, monitoring and re-evaluation of suppliers must be conducted at defined intervals or upon significant changes. Organizations must document performance metrics, audit results, nonconformity trends, and any requalification decisions based on risk and supplier performance.
• Quality Agreements: As per Clauses 4.1.5 and 7.4.2, quality agreements must clearly define product specifications, quality requirements, change control requirements, and regulatory responsibilities. Organizations must also ensure quality agreements are retained in accordance with document control procedures.
• Verification of Purchased Product: As per Clause 7.4.3, the purchased product must be verified against defined acceptance criteria before use or release.  Where verification is performed at the supplier site, alternative, documented controls must be in place, such as supplier audits or validated processes. This ensures conformity of supplied products.
• Documentation and Traceability: When processes are outsourced, manufacturers must ensure control through contracts, audits, or supplier QMS certification. As per Clauses 4.2.4 and 4.2.5, supplier records of agreements, supplier evaluations, and supplier audit results must be maintained within the QMS.  As per Clause 7.5.9.2, organizations must require suppliers of distribution services to maintain distribution records for implantable medical devices to support full device traceability.

21 CFR Part 820 Supplier Management Requirements

21 CFR Part 820 is the FDA’s Quality System Regulation (QSR) that outlines the current good manufacturing practices (cGMPs) required for medical device manufacturers to market their medical devices in the United States. It establishes comprehensive quality system requirements across all aspects of design, production, and distribution.

Supplier management requirements under 21 CFR part 820 are specified under 21 CFR 820.50, Purchasing Controls, which requires that manufacturers establish and maintain procedures to ensure that purchased or received products and services conform to specified requirements. The requirements outlined cover supplier evaluation, purchasing documentation, oversight, and traceability.

The primary supplier management requirements under 21 CFR Part 820.50 are listed below.

• Supplier Evaluation and Selection: As per 21 CFR Part 820.50(a), manufacturers must establish documented procedures to evaluate and select suppliers based on their ability to meet specified quality and regulatory requirements. Objective evidence of evaluation, such as audit reports, certifications (ISO 13485), and past performance, must be maintained.
• Documented Purchasing Data: As per 21 CFR Part 820.50(b), purchasing documents must clearly describe requirements for products and services, which may include specifications, standards, certifications, and applicable regulatory requirements. These documents must be reviewed and approved by designated personnel, for example, the Quality Manager, before release.
• Supplier Agreements and Responsibilities: As per 21 CFR Part 820.50(b), supplier agreements must clearly define supplier responsibilities for notifying the manufacturer of any process or product changes that may affect the device. Manufacturers must ensure ongoing communication and oversight to maintain compliance.
• Recordkeeping and Traceability: As per 21 CFR Part 820.50(a)(3), records of supplier evaluations, purchasing controls, change notifications, and nonconformities must be maintained in a controlled manner. These records serve as objective evidence during inspections and must support traceability to specific devices or product lots, as required.

MDR Supplier Management Requirements

MDR includes supplier control as a core component of the manufacturer’s Quality Management System (QMS), applicable to all external parties whose deliverables directly affect the safety, clinical performance, or regulatory compliance of the finished medical device.

Supplier control requirements in the MDR are outlined in Article 10(9)(d), Annex II, Section 3(c), Annex IX, Annex VII, and Article 93. These requirements establish expectations for identifying, controlling, and auditing suppliers and subcontractors whose activities may affect product conformity.

The primary requirements for supplier management under EU MDR are listed below.

• Supplier and Subcontractor Control in the QMS: As per Article 10(9)(d) and Annex IX Section 2.2, the QMS must address the selection and control of suppliers and subcontractors as part of resource management.
• Design and Manufacturing Information: As per Annex II, Section 3(c), manufacturers must specify which suppliers and subcontractors are involved in the design and production of the device, including their roles and responsibilities.
• Notified Body Audits: Under Annex IX, Sections 2.3 and 3.3, Notified Bodies must assess the manufacturer’s control over critical suppliers during conformity assessments. Annex VII, Section 4.5.2(a) further requires Notified Bodies to audit supplier sites where outsourced processes may significantly impact device safety or performance. This may include unannounced audits where appropriate.
• Competent Authority Audits: As per Article 93(3)(b), Competent Authorities shall carry out both announced and, if necessary, unannounced inspections at the premises of suppliers and subcontractors, as part of their market surveillance activities.

IVDR Supplier Management Requirements

IVDR establishes supplier and subcontractor control as a regulated component of the manufacturer’s Quality Management System (QMS).

Supplier management requirements in the IVDR are defined in Article 10(8)(d), Annex II, Section 3.2(b), Article 88, Annex VII, and Annex IX. These sections outline requirements for the selection, qualification, and oversight of suppliers and subcontractors involved in manufacturing or other critical processes such as product testing or sterilization.  

The primary IVDR supplier management requirements are listed below.

• Supplier Control: IVDR Article 10(8)(d) requires that the manufacturer’s QMS include supplier and subcontractor oversight. In addition, Annex II, Section 3.2 (b) requires identification of all sites, including suppliers and subcontractors, where design or manufacturing activities are performed.
• Audits of Supplier/Subcontractor Sites: Article 88 authorizes Competent Authorities to perform announced or unannounced audits at supplier or subcontractor sites. These audits are risk-based and may be initiated as part of routine surveillance or in response to noncompliance.
• Audits of Critical Suppliers: As per Annex VII, Section 4.5.2, and Annex IX, Sections 2.3 and 3.3, Notified Bodies must assess the relationship between manufacturers and suppliers to determine how outsourced processes impact product conformity. If a critical process (such as sterilization) is outsourced, the notified body is required to audit the supplier and verify compliance. This may include unannounced audits where appropriate.
• Supplier Oversight in Post-Certification Surveillance: Annex VII, Section 4.10 requires notified bodies to include suppliers and service providers in post-certification surveillance. This is applicable if their activities affect product quality, testing, or compliance. Surveillance audits ensure continued oversight of high-risk outsourced processes throughout the product lifecycle.

EU GMP Supplier Management Requirements

GMP supplier management requirements refer to the controls that pharmaceutical manufacturers must implement to ensure that all materials, components, and outsourced activities meet EU GMP standards for product quality and regulatory compliance. For drug-device combination products, GMP requirements ensure that the pharmaceutical attributes of the product meet the regulatory and quality expectations.

Supplier management requirements are defined in the EU GMP Chapter 5, Production, and Chapter 7, Outsourced Activities.

The primary supplier management requirements under EU GMP are outlined below.

• Supplier Qualification and Approval: As per EU GMP Chapters 5 and 7, manufacturers must establish documented procedures to qualify and approve suppliers of starting materials, packaging components, and outsourced manufacturing services. Supplier qualification must consider GMP compliance, audit results, technical capability, and historical performance.
• Quality Agreements and Quality Contracts: As per EU GMP, Chapter 5.28 and Chapter 7.14, written quality agreements must be in place for all suppliers and outsourced GMP activities. These agreements must clearly describe roles, responsibilities, and GMP requirements to be met, including specifications, change control, complaint handling, and deviation management.
• Material and Component Control: As per GMP Chapter 5, Starting Materials and Packaging Materials, the selection, qualification, approval, and monitoring of suppliers must be documented within the pharmaceutical quality system. This includes purchasing only from approved suppliers and establishing appropriate controls for material acceptance. Any outsourced test must be under full oversight of the manufacturer, who retains responsibility for product quality.
• Auditing and Oversight: As per GMP Chapters 7.4 and 7.5, the manufacturer’s pharmaceutical quality system must ensure control and review of all outsourced activities. This includes assessing the legality, suitability, and competence of the supplier or subcontractor before outsourcing, and ensuring, through contractual agreements, that all activities are conducted in compliance with GMP. Quality risk management principles must be applied to these oversight processes.

U.S. GMP Supplier Management Requirements

U.S. Good Manufacturing Practice (GMP) requirements for supplier management are defined under FDA 21 CFR Parts 210 and 211. These apply to the pharmaceutical component of drug–device combination products intended for the U.S. market. Manufacturers are responsible for ensuring that all components, raw materials, and outsourced services conform to specifications. In addition, manufacturers are also responsible for ensuring that the drug–device combination product as a whole meets all applicable regulatory requirements.

The primary supplier management requirements under 21 CFR Parts 210/211 are outlined below.

• Component Testing and Supplier Evaluation: As per 21 CFR Part 211.84(a–d), each lot of components, containers, and closures must be tested or examined for conformance to written specifications. Identity testing is required for each component batch, unless the reliability of the supplier’s test results has been established through appropriate validation. Records must be maintained for each shipment as per 21 CFR Part 211.184.
• Contractual Responsibilities: As per 21 CFR Part 211.22(a-d), the quality control unit must approve or reject drug products manufactured under contract. While 21 CFR 211.22(d) requires quality control responsibilities to be in writing, the FDA strongly recommends (through guidance) that written quality agreements define contractual roles and responsibilities when manufacturing or testing operations are delegated to contract facilities.

MDSAP Supplier Management Requirements

MDSAP outlines harmonized supplier management expectations across participating regulatory authorities: the U.S. FDA, Health Canada, ANVISA (Brazil), TGA (Australia), and MHLW/PMDA (Japan).

Supplier control requirements in the MDSAP are detailed in Chapter 7, Purchasing of the MDSAP Audit Model. In addition, MDSAP also outlines additional country-specific requirements that need to be met.

The primary supplier management requirements under MDSAP Chapter 7 are listed below.

• Risk-Based Supplier Evaluation and Selection: As per Chapter 7, Tasks 4 and 5, manufacturers must establish documented procedures and defined criteria to assess and select suppliers, based on their ability to meet technical and regulatory requirements. Evaluations must be risk-based and consider the impact of the supplier’s output on product conformity, including critical suppliers of sterilization, software, or contract manufacturing.
• Purchasing Controls and Specifications: As per Chapter 7, Task 8, Purchasing documents must define quality and technical requirements, including inspection criteria, acceptance conditions, and supplier requirements. A written agreement must be established with the supplier that ensures notification of any changes.
• Supplier Monitoring and Re-Evaluation: As per Chapter 7, Task 7, supplier monitoring must include review of quality data such as nonconformance trends, complaint data, delivery records, and audit outcomes. Re-evaluation frequency must be risk-based and consistent with the significance of the supplied product on the finished device.
• Control of Outsourced Processes: As per Chapter 7, Tasks 3 and 7, manufacturers must maintain effective control over outsourced activities that affect product quality. This includes ensuring the continued capability of the supplier to provide a product that meets specified requirements.  
• Verification of Purchased Product: As per MDSAP Chapter 7, Task 10, manufacturers must define and perform risk-based acceptance activities. This includes an inspection, testing, or document review to verify that purchased products meet specified requirements before use. These controls must be appropriate to the product’s criticality and supported by documented acceptance criteria.
• Records of Purchasing Activities: As per MDSAP Chapter 7, manufacturers must maintain comprehensive, traceable records of supplier evaluation, approval, re-evaluation, and ongoing performance monitoring. Documentation must include defined purchasing specifications, verification outcomes, supplier agreements, and risk-based justification for supplier status. These records must demonstrate conformity to quality and regulatory requirements and provide objective evidence during inspections or certification audits.

What is the Medical Device Supplier Management Process?

The medical device supplier management process involves the following steps.

1. Supplier Identification and Classification: Identify potential suppliers and categorize them by risk, criticality of product or service, and potential impact on product conformity.
2. Supplier Qualification and Approval: Assess supplier capability through audits, documentation review, and risk-based evaluation to formally approve qualified providers.
3. Contracting and Quality Agreements: Define responsibilities, purchasing specifications, change control, and compliance requirements in signed quality agreements.
4. Onboarding and Initial Assessments: Integrate the supplier into the QMS by verifying certifications, conducting risk-based audits, and defining control measures such as incoming inspections. Confirm the supplier’s capabilities to meet technical and regulatory requirements before approval.
5. Creating and Maintaining the ASL: Maintain a controlled, up-to-date ASL, including supplier risk classification and approval status.
6. Performance Monitoring: Track supplier metrics (delivery, defect rates, audit results) and document performance trends for review. Use this data to identify systemic issues and initiate supplier improvement actions or escalate to SCARs if needed.
7. Risk Management and Non-Conformance Handling: Record supplier-caused nonconformities, evaluate risk impact, and trigger CAPA or requalification as needed.
8. Supplier Communication and Relationship Management: Establish regular communication channels for change notifications, quality updates, and compliance reviews. Ensure communication is documented and aligned with quality agreements, including predefined escalation paths for critical issues.
9. Change Management and Requalification: Review and approve supplier-driven changes to processes, materials, or facilities with updated risk assessments and requalification.
10. Re-evaluation, Audits, and Continuous Improvement: Periodically reassess suppliers based on risk classification, nonconformities, or process changes to ensure suitability and compliance. Conduct scheduled or for-cause audits and use performance data as input for management reviews, CAPA, and continuous improvement initiatives.

1. Supplier Identification and Classification

Supplier identification and classification are the foundational steps in establishing a risk-based supplier management system. Supplier identification and classification involve identifying potential or existing suppliers and classifying them based on the criticality of the materials, components, or services they provide to the medical device’s safety, performance, and regulatory conformity.

Manufacturers must evaluate each supplier’s impact on product quality, intended use, and compliance requirements. This includes assessing whether the supplier provides essential elements such as sterile packaging, critical components, contract manufacturing services, or software used in or for the device.

Suppliers are categorized into defined risk tiers (critical, major, or minor) based on objective criteria such as patient safety impact, product quality and performance effects, regulatory compliance exposure, and business continuity risk. This classification determines supplier risk, audit frequency, supplier monitoring requirements, and documentation expectations throughout the supplier lifecycle.

2. Supplier Qualification and Approval

Supplier qualification and approval is the documented process of evaluating a supplier’s ability to meet regulatory, technical, and quality requirements before being added to the ASL. Manufacturers must define supplier qualification criteria based on supplier criticality, such as ISO 13485 certification, validated processes, and regulatory compliance history.

Supplier evaluation includes reviewing controlled QMS documentation (quality manuals, procedures), conducting audits based on risk classification, and confirming process controls that impact conformity of supplied products. Documentation review should examine compliance history, including any regulatory observations (FDA 483s, NB nonconformities).

Final approval must involve input from Quality, Regulatory, and Purchasing. This ensures the supplier can meet the required specifications, quality, and regulatory requirements, delivery commitments, and business continuity expectations.

3. Contracting and Quality Agreements

Contracting and quality agreements formalize the commercial and quality obligations between the manufacturer and the supplier. Contracting and quality agreements include drafting and executing supply agreements that define product specifications, delivery expectations, and liability terms. Quality agreements also include regulatory requirements, responsibilities, and communication protocols.

Quality agreements must include clauses for compliance with ISO 13485:2016, 21 CFR Part 820, or MDR/IVDR (as applicable), the right to audit, change notification procedures, and record retention periods. These contracts ensure alignment between parties, reduce ambiguity during audits, and protect the manufacturer from regulatory or quality risks due to supplier noncompliance.

4. Onboarding and Initial Assessments

Onboarding and initial assessments involve formally entering an approved supplier into the quality system following supplier qualification. Onboarding includes setting up the supplier in the QMS, providing necessary documentation (specifications, change control procedures), and delivering initial quality and compliance training where needed. Pilot runs or validation batches should be conducted to verify that supplied components meet functional and regulatory requirements under routine conditions, if applicable.

Once the supplier’s capabilities are confirmed and a review of their documents and records is complete, they are added to the ASL for ongoing procurement. This step ensures regulatory readiness and traceability from the start of the supplier relationship.

5. Creating and Maintaining the ASL

Creating and maintaining the ASL involves documenting qualified suppliers in a controlled register. ASL ensures only approved suppliers are used for materials or services.

Manufacturers must establish criteria for the inclusion of suppliers in the ASL. This includes defining requirements for supplier qualification, current certifications, risk classification, and signed quality agreements. The criteria for inclusion must also define triggers for removal, like unresolved nonconformities or expired approvals.

The ASL must be maintained in a controlled system (validated QMS), with version control, defined ownership, and an audit trail to ensure traceability. Periodic reviews must be scheduled to verify supplier status, monitor performance trends, and confirm continued compliance with internal requirements and applicable standards as outlined in ISO 13485 Clause 7.4.1.

The illustration below shows the key elements of an approved supplier list.

6. Performance Monitoring

Performance monitoring is the ongoing evaluation of supplier performance using defined metrics. Performance monitoring ensures that supplied products and services continue to meet quality and regulatory requirements.

Manufacturers must track supplier performance indicators such as on-time delivery rates, non-conformance frequency, defect rates, responsiveness to corrective actions, and adherence to quality agreement terms. These performance metrics should be captured consistently and visualized using supplier scorecards or dashboards maintained in a QMS.

Performance data must be reviewed at defined intervals (quarterly or semi-annually) by cross-functional teams, and used to identify trends, initiate SCARs, or trigger risk reclassification. The performance monitoring process supports early detection of declining supplier quality, enables proactive mitigation, and fulfills ISO 13485 Clause 7.4.1 and 21 CFR 820.50 requirements for ongoing supplier evaluation.

7. Risk Management and Non-Conformance Handling

Risk management and non-conformance handling are the systematic identification, evaluation, and control of supplier-related risks and quality issues to ensure sustained compliance and product safety.

Manufacturers must continuously monitor risks associated with critical suppliers and log all supplier-caused nonconformances, including incoming inspection failures, audit findings, and complaints. Escalation criteria, such as recurrence of the same issue or ineffective CAPA implementation, must be clearly defined. Based on risk, identified nonconformities may lead to SCARs, supplier requalification, or removal from the ASL.

8. Supplier Communication and Relationship Management

Supplier communication and relationship management involve establishing structured, transparent, and traceable channels. The purpose of supplier communication is to exchange critical quality, regulatory, and performance information throughout the supplier lifecycle.

Manufacturers must hold periodic performance reviews, especially with critical suppliers, to discuss metrics, audit outcomes, nonconformities, and improvement plans. Clear protocols must be defined for communicating change notifications, quality issues (nonconformities, deviations), and regulatory updates to ensure timely risk mitigation and continuous compliance.

Documented communication plans, review minutes, and issue logs provide traceability of supplier interactions. This documentation serves as auditable evidence of supplier oversight, risk mitigation, and fulfillment of quality agreements.

9. Change Management and Supplier Requalification

Change management and supplier requalification are the controlled processes of evaluating and managing supplier changes to materials, processes, equipment, software, or facilities that may impact device quality, safety, or regulatory conformity.

Suppliers must provide advance notification of significant changes through established change control procedures, enabling manufacturers to perform documented impact assessments before implementation. Manufacturers must evaluate each change for its potential effects on validated processes, product specifications, risk controls, or regulatory requirements to determine appropriate requalification activities.

Supplier requalification may involve targeted audits, process capability studies, updated quality agreements, or revised incoming inspection criteria, and all actions must be traceable within the QMS.

10. Re-evaluation, Audits, and Continuous Improvement

Re-evaluation, audits, and continuous improvement are the processes of periodically reassessing approved suppliers through scheduled or for-cause audits and performance reviews.

Manufacturers must define risk-based intervals for supplier re-evaluation, considering supplier criticality, quality data, nonconformities, or changes to processes. Re-evaluation activities include performance data analysis, quality agreement compliance reviews, and on-site or remote audits as determined by supplier risk classification.

Audits must verify continued supplier compliance with documented quality agreements, regulatory requirements, and internal specifications by assessing traceability, process controls, and objective evidence of conformity (inspection results, training logs, corrective action implementation, record maintenance practices). Identified gaps must be documented, risk-assessed, and escalated into the CAPA system, as appropriate. Suppliers must identify corrective actions tied to root cause analysis and effectiveness checks, where applicable. Supplier audit results should be reviewed during management review and used to update risk files, audit schedules, and supplier status within the ASL.

How Does QMS Software Support Medical Device Supplier Management Processes?

QMS software supports medical device supplier management by offering a centralized, validated system to plan, execute, monitor, and document supplier-related activities in compliance with ISO 13485:2016, FDA 21 CFR Part 820, and EU MDR/IVDR.

QMS software ensures that supplier qualification records, risk classifications, audit reports, and quality agreements are stored under version control, linked to applicable clauses, and readily accessible during inspections. The software also supports traceability from supplier onboarding through performance monitoring and requalification, helping manufacturers maintain compliance throughout the supplier lifecycle.

QMS software streamlines supplier oversight by automating key processes such as supplier audit scheduling, CAPA initiation, change control, and ASL management. Supplier-related findings can be escalated into CAPA workflows where applicable, with root cause analysis, and documented effectiveness checks. This is tracked in an audit-ready system with 21 CFR Part 11-compliant signatures and time-stamped records.

SimplerQMS provides a medical device QMS software purpose-built for medical device companies operating in regulated environments. SimplerQMS also includes supplier management capabilities. Besides supplier management, SimplerQMS supports a wide range of interconnected QMS processes, including change control, document control, CAPA, training, audits, and more within a single validated system. It supports compliance with ISO 13485:2016 Clause 7.4 (Purchasing Process), FDA 21 CFR Part 820.50 (Purchasing Controls), MDR/IVDR, and validation requirements per ISO 13485 and 21 CFR 820.

SimplerQMS is validated according to GAMP 5 and reduces the validation burden while maintaining compliance with software validation requirements as per ISO 13485 and 21 CFR 820.

How Does Supplier Management for Medical Devices Differ from Pharmaceuticals?

The main difference between supplier management for medical devices and pharmaceuticals lies in the regulatory requirements, risk control expectations, and supplier qualification criteria.

Medical device supplier management is performed as per ISO 13485:2016 Clause 7.4, FDA 21 CFR 820.50, and EU MDR/IVDR, with an emphasis on risk-based controls, traceability, design validation inputs, and integration of supplier oversight within the QMS. Manufacturers must evaluate suppliers based on the criticality of their deliverables, such as sterilization services, software components, or contract manufacturing. Manufacturers must implement controls such as Supplier Quality Agreements (SQAs), risk-based audits, performance monitoring, and documented requalification, ensuring traceability and conformity across the device lifecycle.

Pharmaceutical supplier management is governed by EU Good Manufacturing Practices (GMP), specifically Chapter 5 (Production) and Chapter 7 (Outsourced Activities) for the pharmaceutical part. For drug–device combination products marketed in the U.S., the drug constituent must also comply with U.S. GMP requirements under 21 CFR Parts 210/211. Pharmaceutical supplier management focuses on the identity, purity, and consistency of raw materials, excipients, Active Pharmaceutical Ingredients (APIs), and packaging components. Supplier qualification involves audits to verify GMP adherence, environmental and contamination control measures, analytical method validation, and data integrity systems. Documentation such as Certificates of Analysis (CoAs), Quality Technical Agreements (QTAs), supplier questionnaires, and validated change control records must be traceable, current, and integrated into the overall quality system.